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Single Use Injector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192498
510(k) Type
Traditional
Applicant
Olympus Medical Systems Corp.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
4/28/2020
Days to Decision
230 days
Submission Type
Summary

Single Use Injector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192498
510(k) Type
Traditional
Applicant
Olympus Medical Systems Corp.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
4/28/2020
Days to Decision
230 days
Submission Type
Summary